GMP training qualification

Step by step

1. Assign controlled training Training Coordinator

   Training Coordinator checks the employee, organization, module and owner, then records an assigned item with site and expected completion date.

   • Set module, employee, site and owner
   • Updates Pharma staff assignments, Controlled training modules, Employees

2. Record learning Training Coordinator

   Training Coordinator moves work into progress and adds training lines with dates, hours, source references and observed outcomes.

   • Keep observed and source evidence linked
   • Updates GMP training records, Evidence documents

3. Assess evidence Training Coordinator

   Training Coordinator enters assessment and passing scores and checks the supporting documents before marking the assignment assessed.

   • Record score and assessed state
   • Updates Pharma staff assignments, GMP training records

4. Review qualification GMP Reviewer

   GMP Reviewer examines the assignment revision, training lines and documents, then records approval, return or rejection with a reason.

   • Record decision for revision
   • Updates Review decisions, Pharma staff assignments
   ApprovalA person approves before the work moves on.

5. Track validity Training Coordinator

   Training Coordinator records qualification and its expiry after approval, then checks approaching or expired qualifications.

   • Record qualified or expired state
   • Updates Pharma staff assignments, State history

6. Resolve follow-up Training Coordinator

   A returned or incomplete case receives an action with assignee, due date and recorded resolution before another review.

   • Record remediation and resolution
   • Updates Follow up actions, Review decisions

Training Coordinator

Prepares the assignment and evidence; GMP Reviewer decides on the recorded revision; HR Manager checks the employee context; Admin maintains access and controlled reference records.